TransGene, NEC, and BostonGene have entered a strategic collaboration to test TG4050, an investigational personalized vaccine that aims to treat ovarian and head and neck cancers, according to a press release.
TG4050 is an individualized therapy that stimulates a patient’s immune system into attacking cancer cells by “teaching” it which cells are malignant — based on the presence of certain mutated cancer proteins, called neoantigens, found in tumor tissues.
The partners will first use NEC’s artificial intelligence-based neoantigen prediction system, which is able to find specific mutations that are present on a patient’s tumor and not in the normal genome. The AI-based system will predict which neoantigens will elicit the strongest immune responses.
Then, using TransGene’s myvac platform, a harmless virus is packed with the genetic instructions for up to 30 of these neoantigens, and injected subcutaneously (under the skin). The approach tells the immune system that it should target cells bearing such neoantigens, priming it to eliminate the cancer.
BostonGene will collaborate by analyzing patient tumor samples to identify genetic factors that can predict a patient’s response to the vaccine, and tumor-specific features that can affect that response.
The results of this analysis are presented as a set of intuitive and self-explanatory schematics called a Tumor Portrait Report, meant to visually describe a tumor. The Tumor Portrait Report shows tumor activity, the types of cells found within it, the ways in which a tumor has altered its immediate surroundings — namely its immune-microenvironment — and other tumor-associated processes.
“These Tumor Portrait Reports will help us look at our patient data in light of the current published evidence and could help us accelerate the development of TG4050,” said Éric Quéméneur, PhD, executive vice president and chief scientific officer of Transgene.
TG4050 is currently being evaluated for safety and tolerability among 13 adults with cancers of the ovary, fallopian tube, or peritoneum in an open-label Phase 1 study (NCT03839524). Of note, the peritoneum is a large membrane in the abdominal cavity that connects and supports internal organs.
Other endpoints include the best overall response rate — the proportion of patients with at least a 50% reduction in the ovarian cancer biomarker CA-125 — and the best tumor response rate, which is the proportion of patients attaining partial or complete responses to treatment. The rate of patients who show an immune response to the specific neoantigens in the vaccine also will be assessed as an endpoint.
The trial is recruiting participants at three U.S. locations and one in France. Contact information can be found here.
Under the collaboration, TG4050 also is being tested as a vaccine for head and neck cancer in a separate Phase 1 trial (NCT04183166). This second study is recruiting up to 30 participants with HPV-negative cancers in France. Additional sites in the U.K. also are expected to join.
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